Surgical BioModel BM-IMPLANT

GUDID 09349797001366

Biomodel for implant reference

ANATOMICS PTY LTD

Polyethylene craniofacial tissue reconstructive material Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model Custom-made organ/bone anatomy model

• Primary Device ID: 09349797001366
• NIH Device Record Key: d34f52d7-9870-4c31-975d-1bf2efdcb136
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Surgical BioModel
• Version Model Number: BM-IMPLANT
• Catalog Number: BM-IMPLANT
• Company DUNS: 755739307
• Company Name: ANATOMICS PTY LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +61395298088
• Email: contact@anatomics.com
• Phone: +61395298088
• Email: contact@anatomics.com
• Phone: +61395298088
• Email: contact@anatomics.com
• Phone: +61395298088
• Email: contact@anatomics.com
• Phone: +61395298088
• Email: contact@anatomics.com
• Phone: +61395298088
• Email: contact@anatomics.com
• Phone: +61395298088
• Email: contact@anatomics.com
• Phone: +61395298088
• Email: contact@anatomics.com
• Phone: +61395298088
• Email: contact@anatomics.com
• Phone: +61395298088
• Email: contact@anatomics.com
• Phone: +61395298088
• Email: contact@anatomics.com
• Phone: +61395298088
• Email: contact@anatomics.com
• Phone: +61395298088
• Email: contact@anatomics.com
• Phone: +61395298088
• Email: contact@anatomics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	09349797001366 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171037

FDA Product Code

• HWT: Template
• JOF: Polymer, Ent Synthetic, Porous Polyethylene

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-16
• Device Publish Date: 2020-01-08

Devices Manufactured by ANATOMICS PTY LTD

• 09349797000093 - Surgical Template: 2020-12-04 Surgical Template - BRT
• 09349797002530 - StarPore: 2020-04-13 StarPore Patient Specific Implant (Small)
• 09349797002547 - StarPore: 2020-04-13 StarPore Patient Specific Implant (Medium)
• 09349797002554 - StarPore: 2020-04-13 StarPore Patient Specific Implant (Large)
• 09349797002561 - StarPore: 2020-04-13 StarPore Patient Specific Implant (X-Large)
• 09349797001700 - StarPore: 2020-02-25 StarPore Patient Specific Implant
• 09349797002387 - StarPore: 2020-02-18 StarPore Patient Specific Implant (SAMPLE)
• 09349797000192 - StarPore: 2020-01-16 StarPore Patient Specific Implant (Small)